Home › PTAB Cases › IPR2025-00874

Aquestive Therapeutics, Inc. vs. Iono Pharma, LLC

Explore the PTAB proceeding IPR2025-00874 filed by Aquestive Therapeutics, Inc. on 2025-05-16. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

IPR2025-00874

Filing Date

2025-05-16

Accorded Filing Date

2025-05-16

Institution Decision Date

2025-10-03

Last Modified Date

2026-02-24

Proceeding Type

IPR

Termination Date

2025-10-03

Trial Status

Discretionary Denial

Parties & Counsel

Petitioner

Aquestive Therapeutics, Inc.

Represented By

Scola, Danielet al

Patent Owner / Respondent

Iono Pharma, LLC

Represented By

Ha, Yung-Hoonet al

Tribunal & Venue

Tribunal

Patent Trial and Appeal Board (USPTO)

Technology Center

TC 1600 - Biotechnology & Organic Chemistry

Patent Information

1 Patent Involved

Respondent Application Number 16347625

Respondent Patent Number 11021437

External Links

Espacenet

Google Patents

Respondent Inventor Hassan Almoazen

Respondent Tech Center TC 1600 - Biotechnology & Organic Chemistry

Address and Attorney/Agent Information

1 Registered Practitioner

Power of Attorney & Correspondence

Firm / Entity Name Susan B. Fentress - Veritay Group IP PLLC

Customer Number 76447

Address PO BOX 770029, Memphis, TN, 38117, UNITED STATES

Attorney / Agent Information

Reg #	Name	Phone
31327	Susan Fentress	901-866-1656

Proceeding Documents

113

Notice: refund approved NOTICE

2026-02-24 FILING PARTY: BOARD

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PETITIONER’S REQUEST FOR REFUND OF POST-INSTITUTION FEE OTHER

2026-02-10 FILING PARTY: PETITIONER

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Order Denying Director Review of Institution Decision REHEARING

2025-12-15 FILING PARTY: BOARD

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Patent Owner's Authorized Response to Director Review Request OTHER

2025-11-04 FILING PARTY: PATENT OWNER

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3100

Ex. 3100 Counsel email for authorized response Exhibit

2025-10-28 FILING PARTY: BOARD

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PETITIONER’S REQUEST FOR DIRECTOR REVIEW OF DISCRETIONARY DENIAL DECISION DENYING INSTITUTION OF INTER PARTES REVIEW REQUEST

2025-10-27 FILING PARTY: PETITIONER

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Director Discretionary Decision: Deny RESPONSE

2025-10-03 FILING PARTY: BOARD

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2039

EX2039 - Clinical Trial Arena, Aquestive maps out FDA approval for sublingual anaphylaxis drug Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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1064

Excerpts of quarterly report for the period ending 6-30-2025 filed with the SEC by Aquestive Therapeutics. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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2032

EX2032 - U.S. Patent Publication No. 2018/0104195 Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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1073

6-16-2016 email from Ramona McCudden to Steve Wargacki re: MonoSol Rx (1). Exhibit

2025-09-18 FILING PARTY: PETITIONER

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2038

EX2038 - Healio, FDA accepts new drug application for sublingual epinephrine film Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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1068

Excerpts of quarterly report for the period ending 3-31-2025 filed with the SEC by Aquestive Therapeutics. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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2021

EX2021 - U.S. Provisional No. 62/331,993 Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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1065

Aquestive 6-16-2025 Press Release. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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1070

Prescription Drug User Fee Amendments, https://www.fda.gov/industry/fda-user-fee-programs/ Exhibit

2025-09-18 FILING PARTY: PETITIONER

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Patent Owner's Preliminary Response POPR

2025-09-18 FILING PARTY: PATENT OWNER

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1052

‘437 PCT File History – PCT/US20l7/06076l, filed November 9, 2017. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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1062

U.S. Patent No. 12,023,309. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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1063

U.S. Patent No. 11,273,131. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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1053

A copy of the ‘437 Provisional Application (EX1013) highlighted to show where material from the Almoazen Paper (EX1022) appears. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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2035

EX2035 - HCP Live, Positive Phase 3 Results Announced for Sublingual Epinephrine Treatment Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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1067

Excerpts of 2024 annual report filed with the SEC by Aquestive Therapeutics. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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2028

EX2028 - Jacqueline A. Pongracic and Jennifer S. Kim, Update on epinephrine for the treatment of anaphylaxis, Current Opinion in Pediatrics 94 (2007) Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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2036

EX2036 - Fortune Business Insights, Epinephrine Market Size, Share & Industry Analysis Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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1061

Dribin, et al., “Anaphylaxis definition, overview, and clinical support tool: 2024 consensus report—a GA2LEN project”, https://doi.org/10.1016/j.jaci.2025.01.021 Exhibit

2025-09-18 FILING PARTY: PETITIONER

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Petitioner’s First Updated Exhibit List NOTICE

2025-09-18 FILING PARTY: PETITIONER

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2027

EX2027 - Keith J. Simons and F. Estelle R. Simons, Epinephrine and its use in anaphylaxis: current issues, Current Opinion in Allergy and Clinical Immunology 354 (2010) Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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2024

EX2024 - Aquestive Therapeutics June 16, 2025, Press Release Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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2030

EX2030 - Xiaochen Gu et al., Is Epinephrine Administration by Sublingual Tablet Feasible for the First-Aid Treatment of Anaphylaxis? A Proof-of-Concept Study, Biopharmaceutics & Drug Disposition (2002) Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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2029

EX2029 - Phil Lieberman, Use of epinephrine in the treatment of anaphylaxis, Current Opinion in Allergy and Clinical Immunology 313 (2003) Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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2025

EX2025 - FDA GSRS UNII Substance Record — Dibutepinephrine (UNII: 3ZU4LVA3G9) Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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1060

Motosue, et al, “Risk factors for severe anaphylaxis in the United States”, Ann Allergy Asthma Immunol 119 (2017) 356-361. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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1071

5-27-2016 email from Steve Wargacki to Ramona McCudden re: Possible candidate source. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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2033

EX2033 - Dipivefrin: “Uses, Interactions, Mechanism of Action.” DrugBank Online. Retrieved September 4, 2025 Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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1066

Excerpts of 2023 annual report filed with the SEC by Aquestive Therapeutics. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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2037

EX2037 - Stock Titan, Aquestive Therapeutics Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for Anaphlym Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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1075

Declaration of Romona Mccudden, Recruiting Specialist at Petitioner Aquestive Therapeutics, Inc. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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2022

EX2022 - U.S. Provisional No. 62/929,737 Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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2034

EX2034 - FDA News Release, FDA Approves First Nasal Spray for Treatment of Anaphylaxis Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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1072

6-3-2016 email from Ramona McCudden to Steve Wargacki re: MonoSol Rx (2). Exhibit

2025-09-18 FILING PARTY: PETITIONER

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1069

Excerpts of quarterly report for the period ending 6-30-2025 filed with the SEC by Aquestive Therapeutics. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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2031

EX2031 - F. Estelle R. Simons et al., Can Epinephrine Inhalations Be Substituted for Epinephrine Injection in Children at Risk for Systemic Anaphylaxis? 106 Pediatrics 1040 (2000) Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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1074

10-23-2016 email from Steve Wargacki to Ramona McCudden re: email from Almoazen. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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1054

Schobel Provisional, Provisional Application, serial no. 62/331,996, filed May 5, 2016, to Schobel U.S. 11,191,737. Exhibit

2025-09-18 FILING PARTY: PETITIONER

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2026

EX2026 - F. Estelle R. Simmons, First-aid treatment of anaphylaxis to food: Focus on epinephrine, 113 Journal of Allergy and Clinical Immunology 837 (2004) Exhibit

2025-09-18 FILING PARTY: PATENT OWNER

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Petitioner’s Brief Opposing Discretionary Denial RESPONSE

2025-09-18 FILING PARTY: PETITIONER

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Patent Owner's Discretionary Denial Brief RESPONSE

2025-08-18 FILING PARTY: PATENT OWNER

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2001

EX2001 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2002

EX2002 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2016

EX2016 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2017

EX2017 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2003

EX2003 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2011

EX2011 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2010

EX2010 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2004

EX2004 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2019

EX2019 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2009

EX2009 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2007

EX2007 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2020

EX2020 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2013

EX2013 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2015

EX2015 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2008

EX2008 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2014

EX2014 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2018

EX2018 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2005

EX2005 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2006

EX2006 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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2012

EX2012 Exhibit

2025-08-18 FILING PARTY: PATENT OWNER

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Notice: Patent Owner's Power of Attorney NOTICE

2025-06-18 FILING PARTY: PATENT OWNER

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Notice: Patent Owner's Mandatory Notice NOTICE

2025-06-18 FILING PARTY: PATENT OWNER

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Notice: Notice filing date accorded NOTICE

2025-06-18 FILING PARTY: BOARD

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